510(k) · Cleared
ClearedPyrilinks-D Assay Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Metra Biosystems, Inc. · JMM Column Chromatography & Color Development, Hydroxyproline
Cleared on Jan 26, 1998 after a 74-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Jan 26, 1998
- Review
- 74 days
- Class
- Class I
- Product code
- JMM
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK974260 Pyrilinks-D Assay KitMetra Biosystems, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK980833 Immulite Pyrilinks-D Model Numbers LKPD1, LKPD5Diagnostic Products Corp. · 1998
Most influential descendants
Showing 1 of 1 · See all- K980833Immulite Pyrilinks-D Model Numbers LKPD1, LKPD5Diagnostic Products Corp. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974260 | Pyrilinks-D Assay Kit | Metra Biosystems, Inc. | 1998 | — |
| +1 | K980833 | Immulite Pyrilinks-D Model Numbers LKPD1, LKPD5 | Diagnostic Products Corp. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JMM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K980833 | Immulite Pyrilinks-D Model Numbers LKPD1, LKPD5 | 1998 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K980833 (Diagnostic Products Corp., 1998) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JMM devicesJMM Column Chromatography & Color Development, Hydroxyproline: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JMM
FDA has decided no JMM device since 2007.
Median 510(k) review, days · JMM
Too few JMM 510(k)s in any year since 2007 to give a median.
Recalls per year · JMM
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JMM
1in 2025
MAUDE reports naming product code JMM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Pyrilinks-D is a urinary assay that provides a quantitative measure of the excretion of deoxypyridinoline (Dpd) crosslinks as an indicator of bone resorption. Elevated levels of urinary Dpd indicate elevated bone resorption in individuals. Mecasurement of Dpd is intended for use in monitoring bone resorption changes in postmenopausal women receiving antiresorptive therapies and in individuals diagnosed with-osteoporosis.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974260 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974260: Pyrilinks-D Assay Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974260
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026